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FULL TEXT OF FDA'S RESPONSE TO
QUESTIONS FROM FOX 13 INVESTIGATIVE REPORTER
What is the FDA's knowledge of insulin dependent
diabetics who claim they cannot stabilize on
Humulin and require beef or beef/pork animal
are patients who report that they have more
hypoglycemia with human insulin than with animal
insulin. For these individuals, pork insulin
continues to be available (Lilly's Iletin 2
line) in the U.S. Patients who believe that they
cannot use human insulin can use pork insulin.
It is notable that since the approval of the
first human insulin product in the early 1980's,
most newly diagnosed Type I diabetics are
treated from the start with human insulin.
For some patients being treated with animal
insulin, the switch from animal insulin to human
insulin may be complex. The drugs are not
directly interchangeable for a variety of
reasons. Intrinsic characteristics of the drug
products that affect their speed of onset and
duration of action may lead to more or less
pronounced effects on glucose levels depending
on the specific product used. In addition, most
people taking animal insulins develop antibodies
to the foreign insulins that affect speed of
onset and duration of action. When such
individuals switch to human insulins, the levels
of these antibodies fall such that the speed of
onset and duration of action of the human
insulins are not similarly affected.
For these and other reasons, diabetics who
switch from animal to human insulin products
should do so under the guidance of a physician
and may need to initiate therapy with a lower
dose of the human insulin and carefully titrate
their human insulin dose.
None of the points mentioned above is intended
to suggest differences in the safety of animal
insulins versus human insulins. All insulins can
cause hypoglycemia, an adverse effect that may
be associated with severe consequences including
seizure, coma, heart attack, stroke, and in rare
instances, death. It is important to note that
most patients can switch to human insulin
2. Does the FDA acknowledge that Humulin may
not work well for some people? If so, what would
the approximate number be?
the answer to question 1. As above, most
patients are able to switch from animal insulins
to human insulin without difficulty.
Nevertheless, this switch should be undertaken
with physician supervision, and, as stated
previously, pork insulin products are still
available in the U.S. for those patients who
believe that they cannot use human insulin. We
do not have a reliable estimate of the number of
patients who believe that they cannot use human
3. What is the FDA doing to help these
As you know, Lilly recently stopped U.S.
marketing of Iletin 1 (beef/pork insulin mixture
containing mostly beef insulin). Lilly's
decision to stop marketing Iletin 1 was a
corporate decision and was not made at the
request of the FDA. Thus, at present no beef
insulin-containing product is marketed in the
U.S., however, as noted above Lilly continues to
market a pork insulin product in the U.S. It is
important to note that there has not been a pure
beef insulin product on the market in the U.S.
for a number of years.
The FDA is willing to work with any sponsor
interested in marketing animal insulins in the
U.S. Approval of any new animal insulin product
will require that the sponsor submit data to the
FDA to assure that the new insulin product meets
the standards established by the Food, Drug, and
Cosmetic Act for safety, effectiveness, and
quality. The FDA has met with sponsors
interested in marketing beef insulin products in
the U.S. on a number of occasions and has worked
to reduce the regulatory burdens the sponsors
must meet to obtain FDA approval for their beef
insulin products. An important safety concern
for beef insulin is possible contamination with
the agent that causes bovine spongiform
encephalopathy (BSE). This concern raises issues
related not only to the sources of bovine
pancreas (i.e., from BSE-free herds) but also
related to processing in designated plants to
avoid potential contamination with BSE from
materials from non-BSE-free herds.
In addition, FDA has exercised its regulatory
discretion to allow personal importation of
unapproved beef insulin (up to a 6-month supply)
by patients whose doctors certify cannot be
controlled on other available therapy.
4. Why isn't the FDA doing more to make
doctors and diabetics aware that a problem may
The FDA website has detailed information on the
beef insulin issue, including the safety
concerns surrounding the use of non-U.S.
approved beef insulin products. In addition, it
provides explicit information on importation for
personal use. While FDA cannot endorse the use
of products that have not been determined by FDA
to be safe and effective for human use, we do
describe the mechanism by which patients can
obtain beef insulin (up to a 6-month supply) for
personal use through special importation
procedures. As noted above, FDA has exercised
its regulatory discretion to allow personal
importation of beef insulin.
5. How does the FDA interpret its own adverse
reaction data where diabetics and/or their
families have blamed Humulin or Humulin for
deaths and hospitalizations.
Insulins, whether animal or human, can cause
hypoglycemia and serious adverse reactions
related to hypoglycemia. As stated above, some
individuals have difficulty switching from
animal to human insulins. This should be
undertaken with physician supervision, and if
patients still cannot tolerate human insulin,
pork insulin is available in the U.S. and beef
insulin may be imported for personal use.
6. What investigating has the FDA done to
follow-up on those adverse reaction reports?
We are aware of these reports and they have been
evaluated through the same process that FDA uses
to evaluate all adverse event reports received
for marketed drugs. Adverse events related to
hypoglycemia have been received for all types of
insulin products, and underscore the importance
of careful dosing and titration of insulin in
addition to other interventions (e.g., dietary
compliance) to assure the safe use of these
7. What dialogues have taken place between
the FDA and CP Pharmaceuticals of the UK?
For reasons of confidentiality we are not at
liberty to discuss interactions between FDA and
a drug sponsor.
8. Why does the FDA consider the UK insulin a
BSE risk when the company uses American cows?
Regardless of the specific commercial sponsor,
the potential for BSE contamination of beef
insulin is related not only to the source of
livestock but also to the manufacturing
facilities and equipment used to process the
material into the final drug product. Material
obtained from BSE-free herds may become
contaminated if processed in the same facilities
and using the same equipment that are used to
process materials from herds that are not
certified to be BSE free.
9. What is the FDA requiring the UK company
to do to be able to sell and market its insulin
in the US?
For reasons of confidentiality we are not at
liberty to discuss interactions between FDA and
a drug sponsor on development of a drug product
for U.S. approval. FDA has met on several
occasions with sponsors interested in gaining
approval to market beef insulin in the U.S. and
we remain committed to working with any sponsor
interested in submitting the data necessary to
gain FDA approval for beef insulin.
10. How long will that process take?
It is not possible to comment on how long the
approval process for beef insulin might take.
When FDA receives an application for approval of
beef insulin that is satisfactory for filing and
review, the application will be reviewed and a
decision regarding approval will be made in the
time frames required by the Prescription Drug
User Fee Act as amended in 1997.
11. Can the FDA do anything to fast-track the
process? Or is there a compromise that can be
reached? If so, what would it take?
As noted above, FDA is willing to work with any
sponsor that is interested in submitting an
application for marketing of beef insulin that
contains the data required to demonstrate the
safety, effectiveness, and quality of their beef
insulin product. As always, the FDA will
entertain proposals from sponsors on how they
may gather the necessary data in the least
burdensome way, without compromising the safety
of the product.
12. Does the FDA in any way consider this an
emergency or a crisis?
As stated above, there are many insulin products
available as options for patients with diabetes
who require insulin for control. These include
various types of human insulins, pork insulins,
and, if necessary, the option of personal
importation of beef insulin. Recognizing that
some patients believe that their diabetes cannot
be controlled without beef insulin, FDA has
exercised its enforcement discretion to allow
importation of unapproved beef insulin for
personal use. We have worked to make the
personal importation process less burdensome for
patients including allowing patients to receive
up to a six-month supply rather then the usual
three-month supply. We believe that working with
their individual physician, patients can utilize
one or more of the available insulin options to
treat their diabetes safely and effectively.
13. Some diabetics claim the FDA is
"protecting them to death." What is
As noted above, patients have many insulin
options, including the option to obtain beef
insulin through personal importation if their
doctor believes that beef insulin is necessary
for their care. We believe that in order to
fulfill FDA's public health mission, the
potential risk of BSE contamination of beef
insulin must be taken very seriously and
adequately addressed before any beef insulin
product is approved for U.S. marketing. We have
tried to balance these public health concerns
with the needs of individual patients by
exercising our enforcement discretion to allow
personal importation of beef insulin.
14. Anything else the FDA would like to add
relating to this that perhaps has not been
covered in the questions and answers?
Nothing additional. Please direct patients and
physicians to the FDA website for further
information regarding beef insulin.
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